Effects of Dietary Protein Intake and Resistance Training on Retention of Fat Free Mass During Weight Loss in Adults Over 50 with Obesity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Class Attendance
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to examine the separate and combined effects of a high-protein (HP) diet and resistance training (RT) on body composition and potential biological moderators of body weight in women and men >50y. All participants will receive dietary physical activity guidance through our group-based weight loss program, State of Slim (SOS). The SOS program will be delivered via the Zoom videoconferencing platform. These participants will be randomized to receive either a counseling-based HP diet plan or RT plan. Body composition assessments at 8 wk will identify responders and non-responders; the latter will be re-randomized to "augment" (HP: add protein supplements; RT: supervise RT) or "combine" (HP with protein supplements + supervised RT).
Investigators
Drew Sayer
Primary Investigator
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- •Male or Female
- •Age ≥50 years
- •Post-menopausal if Female
- •BMI of 30-50 kg/m2 for ambulatory participants (less than or equal to 350 lbs.)
- •BMI of 25-50 kg/m2 for wheelchair users (less than or equal to 350 lbs.)
- •Ambulatory with or without a walking device or use of a manual wheelchair for mobility.
Exclusion Criteria
- •Untreated hyper or hypothyroidism.
- •Cancer (except basal cell).
- •Gastrointestinal disorders affecting food intake.
- •\<3 months of stable use of medications that affect metabolism, body weight, energy expenditure or appetite.
- •Current eating disorder (e.g., binge eating disorder, anorexia, or bulimia).
- •Any medical condition for which following a HP diet and/or 70 minutes of exercise daily would be inadvisable.
- •Uses a powered wheelchair for mobility.
- •Has a pacemaker or any other life-sustaining medical implant.
Outcomes
Primary Outcomes
Class Attendance
Time Frame: Baseline through week 52.
Class Attendance will be tracked to determine clinical trial feasibility.
2nd Stage Intervention Preference
Time Frame: Week 8
Participant preferences for 2nd stage interventions will be measured at week 8 by answering a 5-point Likert question with '1' and '5' representing a strong preference for either intervention and '3' representing no intervention preference.
Recruitment and Retention Rates
Time Frame: Baseline through week 52.
Rates of study recruitment and retention will be tracked to determine clinical trial feasibility.
1st Stage Intervention Preference
Time Frame: Baseline
Participant preferences for 1st stage interventions will be measured at baseline by answering a 5-point Likert question with '1' and '5' representing a strong preference for either intervention and '3' representing no intervention preference.
1st Stage Treatment Credibility
Time Frame: Baseline.
Perceived credibility of 1st stage interventions will be measured at baseline with the Credibility/Expectancy Questionnaire.
2nd Stage Treatment Credibility
Time Frame: Week 8.
Perceived credibility of 2nd stage interventions will be measured in non-responders to 1st stage interventions at week 8 with the Credibility/Expectancy Questionnaire.
Secondary Outcomes
- Body Weight(Baseline, Weeks 8, 16, and 52)
- Fat mass(Baseline, Weeks 8, 16, and 52)
- Fat free mass(Baseline, Weeks 8, 16, and 52)